Software Development for Medical Devices: Overcoming the Challenges of Compliance, Quality and Cost

Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software innovation are balanced by the risks and challenges of FDA regulation, stringent quality requirements, market pressures, and significant complexity. Balancing these competing interests requires tailored application lifecycle management that addresses the unique needs of medical devices companies.

This paper reviews some of the key challenges facing the medical device industry, and examines the role that an application lifecycle management (ALM) platform can play in meeting these challenges. Primary challenges to be addressed include FDA compliance, device and software quality, and cycle time and cost.